Recalls / Class III
Class IIID-0624-2021
Product
READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01
- Brand name
- Readyprep Chg
- Generic name
- Chlorhexidine Gluconate 2%
- Active ingredient
- Chlorhexidine Gluconate
- Route
- Topical
- NDC
- 53329-244
- FDA application
- NDA207964
- Affected lot / code info
- Lot #:: 19EEA027, Exp May 2021; 19GEA049, Exp August 2021; 19HEA044, Exp Sept 2021
Why it was recalled
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Recalling firm
- Firm
- Medline Industries Inc
- Manufacturer
- Medline Industries, LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Lakes Dr, N/A, Northfield, Illinois 60093-2753
Distribution
- Quantity
- 231,936 packs
- Distribution pattern
- Distributed Nationwide in the USA and Isreal
Timeline
- Recall initiated
- 2021-05-14
- FDA classified
- 2021-06-10
- Posted by FDA
- 2021-06-16
- Terminated
- 2024-08-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0624-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.